A Phase 1 interventional study of Baricitinib and Simvastatin in Healthy Volunteers, sponsored by Eli Lilly and Company. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-06.
Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science
The purposes of this study are to determine the effects of baricitinib on the time it takes to remove simvastatin from the body and to look at how well-tolerated and safe baricitinib is when given alone and in combination with simvastatin. Side effects will be documented. The study will last approximately 7 days from the first dose to the end of the study (not including screening or follow-up).
Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single oral dose of 40 milligrams (mg) simvastatin on Day 1.
Drug: Simvastatin
Oral doses of 10 mg baricitinib once daily (QD) on Days 3 to 7, with a single oral dose of 40 mg simvastatin coadministered on Day 6.
Drug: Baricitinib · Drug: Simvastatin
Administered orally
Also known as: LY3009104
Administered orally
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Simvastatin and Simvastatin Acid
The Cmax of simvastatin \[a cytochrome P450 (CYP) 3A substrate\] and its active acid metabolite (simvastatin acid) is reported.
Time frame: Period 1, Day 1 and Period 2, Day 6: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours postdose
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity [AUC(0-∞)] of Simvastatin and Simvastatin Acid
The AUC(0-∞) of simvastatin (a CYP3A substrate) and its active acid metabolite (simvastatin acid) is reported.
Time frame: Period 1, Day 1 and Period 2, Day 6: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours postdose
| Milestone | Simvastatin Then Baricitinib and Simvastatin |
|---|---|
| Started | 40 |
| Received simvastatin | 40 |
| Completed | 40 |
| Not completed | 0 |
| Milestone | Simvastatin Then Baricitinib and Simvastatin |
|---|---|
| Started | 40 |
| Received at least 1 dose of baricitinib | 40 |
| Received simvastatin | 38 |
| Completed | 38 |
| Not completed | 2 |
| Withdrew: Adverse event | 2 |
The Cmax of simvastatin \[a cytochrome P450 (CYP) 3A substrate\] and its active acid metabolite (simvastatin acid) is reported.
| nanograms per milliliter (ng/mL) | Simvastatin | Baricitinib and Simvastatin |
|---|---|---|
| Simvastatin | 6.85 ± 74 | 4.65 ± 57 |
| Simvastatin Acid | 1.93 ± 68 | 1.60 ± 50 |
The AUC(0-∞) of simvastatin (a CYP3A substrate) and its active acid metabolite (simvastatin acid) is reported.
| nanograms*hour/milliliter (ng*h/mL) | Simvastatin | Baricitinib and Simvastatin |
|---|---|---|
| Simvastatin (n=39, 36) | 40.7 ± 86 | 33.7 ± 75 |
| Simvastatin Acid (n=33, 32) | 26.4 ± 81 | 21.0 ± 64 |
Collected over Baseline through study completion (up to Day 18). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Simvastatin | — | 0/40 (0%) | 3/40 (7.5%) |
| Baricitinib | — | 0/40 (0%) | 1/40 (2.5%) |
| Baricitinib and Simvastatin | — | 0/38 (0%) | 3/38 (7.9%) |
| Event | Simvastatin | Baricitinib | Baricitinib and Simvastatin |
|---|---|---|---|
| HeadacheNervous system disorders | 3/40 | 1/40 | 1/38 |
| NasopharyngitisInfections and infestations | 0/40 | 0/40 | 2/38 |
All enrolled participants.
| Age, Continuous(years) | Simvastatin Then Baricitinib and Simvastatin |
|---|---|
| Mean | 40.0 ± 13.0 |
| Sex: Female, Male(Participants) | Simvastatin Then Baricitinib and Simvastatin |
|---|---|
| Female | 5 |
| Male | 35 |
| Ethnicity (NIH/OMB)(Participants) | Simvastatin Then Baricitinib and Simvastatin |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 40 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Simvastatin Then Baricitinib and Simvastatin |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 39 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Simvastatin Then Baricitinib and Simvastatin |
|---|---|
| United Kingdom | 40 |
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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